BURKHART NEUTRAL- sodium fluoride gel 
Burkhart Dental Supply Inc

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Active Ingredient:

1.1% Sodium Fluoride.

Purpose:

Aids in prevention of dental caries and hypersensitivity. Use as directed by your dentist.

Warnings:

Do not swallow. To avoid ingestion, supervision is required while children are using the product. Keep out of reach of children.

Directions:

Adults and children 6 years of age and older:

Children under 6 years of age:

Store at controlled room temperature 59° - 86°F (15° - 30°C).

Inactive Ingredients:

Calcium Caseinate, Citric Acid, Flavor, Glycerine, Glydant, Sodium Benzoate, Sodium Hexameta Phosphate, Sodium Saccharine, TriCalcium Phosphate, Vitamin E, Water, Xanthan Gum, Xylitol.

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BURKHART NEUTRAL 
sodium fluoride gel
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:43498-301
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.597 g  in 120 g
Inactive Ingredients
Ingredient NameStrength
CASEIN (UNII: 48268V50D5)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
GLYCERIN (UNII: PDC6A3C0OX)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
TRICALCIUM PHOSPHATE (UNII: K4C08XP666)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
WATER (UNII: 059QF0KO0R)  
XANTHAN GUM (UNII: TTV12P4NEE)  
XYLITOL (UNII: VCQ006KQ1E)  
Product Characteristics
Colorwhite (opaque) Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43498-301-04120 g in 1 TUBE; Type 0: Not a Combination Product02/11/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other02/11/2019
Labeler - Burkhart Dental Supply Inc (027532357)

Revised: 2/2019
Document Id: e270b080-56e5-4894-ad4f-01332c7baeaa
Set id: de8b69a7-6d21-4ecf-a614-e78d7a0c2e97
Version: 3
Effective Time: 20190211
 
Burkhart Dental Supply Inc